Effectiveness of Lithium Plus Optimized Medication in Treating People With Bipolar Disorder (LiTMUS)
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ClinicalTrials.gov Identifier: NCT00667745 |
Recruitment Status
:
Completed
First Posted
: April 28, 2008
Results First Posted
: June 28, 2013
Last Update Posted
: February 13, 2018
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Tracking Information | |||
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First Submitted Date ICMJE | April 24, 2008 | ||
First Posted Date ICMJE | April 28, 2008 | ||
Results First Submitted Date | October 25, 2012 | ||
Results First Posted Date | June 28, 2013 | ||
Last Update Posted Date | February 13, 2018 | ||
Study Start Date ICMJE | April 2008 | ||
Actual Primary Completion Date | March 2010 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00667745 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Effectiveness of Lithium Plus Optimized Medication in Treating People With Bipolar Disorder | ||
Official Title ICMJE | Lithium Use for Bipolar Disorder (LiTMUS): A Randomized Controlled Effectiveness Trial | ||
Brief Summary | This study evaluated whether lithium included as part of optimized medication treatment improved overall level of illness, symptoms of mania and depression, and quality of life in people with bipolar disorder. | ||
Detailed Description | Bipolar illness, a brain disorder that causes dramatic changes in a person's mood and energy, affects about 2.6% of adults in the United States. Bipolar disorder is characterized by cyclical periods of extreme highs and lows, known as episodes of mania and depression. A person undergoing an episode of mania often experiences euphoric moods, increased energy, and aggressive behaviors, while a person in a depressed state often experiences low moods, lack of energy, and feelings of sadness. Lithium is a widely used mood stabilizing medication that has been shown to reduce the occurrence and intensity of manic episodes and may lessen depressive episodes as well. Including lithium as a part of a personalized medication treatment approach may be the most effective means of improving symptoms of bipolar disorder. This study will evaluate whether lithium included as part of optimized medication treatment improves overall level of illness, symptoms of mania and depression, and quality of life in people with bipolar disorder. Participation in this study lasted for 6 months. All participants had an initial assessment that included an interview and questionnaires to confirm a diagnosis of bipolar disorder, vital sign measurements, a blood draw, and if female, pregnancy. Eligible participants were then assigned randomly to receive either optimized medication plus lithium or optimized medication without lithium. Participants in both groups received 6 months of monitored treatment with their medication regimens, as prescribed by their study doctor. Participants attended study visits every 2 weeks for the first 8 weeks and then once a month for 4 more months. These visits lasted between 45 and 60 minutes and included medication adjustments and questions about symptoms, side effects, and quality of life. We would like to acknowledge that medication was kindly donated by Ortho-McNeil Janssen Scientific Affairs, LLC. |
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Study Type ICMJE | Interventional | ||
Study Phase | Phase 4 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Bipolar Disorder | ||
Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
283 | ||
Original Estimated Enrollment ICMJE |
264 | ||
Actual Study Completion Date | March 2010 | ||
Actual Primary Completion Date | March 2010 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 80 Years (Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00667745 | ||
Other Study ID Numbers ICMJE | N01 MH080001-01 DSIR AT |
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Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | National Institute of Mental Health (NIMH) | ||
Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | National Institute of Mental Health (NIMH) | ||
Verification Date | July 2010 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |